AstraZeneca Nijmegen B.V.
FDA inspection history in Nijmegen, Netherlands, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Nijmegen, Netherlands.
Cited most
Across all AstraZeneca Nijmegen B.V. observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
The complete AstraZeneca Nijmegen B.V. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Nijmegen, Netherlands
One Form 483 · 2019 · 2 observations
Latest: Form 483, Sep 19, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-19 | 483 Form 483 | Nijmegen, Netherlands | 2 | $99 |
Investigators on these documents
FEI number 3003000472 · most recent document Sep 19, 2019
About AstraZeneca Nijmegen B.V.
How many FDA Form 483s has AstraZeneca Nijmegen B.V. received?
FDA Intel has 1 Form 483 on file for AstraZeneca Nijmegen B.V.; the most recent is dated Sep 19, 2019.
When was AstraZeneca Nijmegen B.V. last inspected by FDA?
The most recent FDA inspection document on file for AstraZeneca Nijmegen B.V. is a Form 483 dated Sep 19, 2019, for the site in Nijmegen, Netherlands.
What did FDA cite at AstraZeneca Nijmegen B.V.?
The regulations cited most in the observations on file for AstraZeneca Nijmegen B.V. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.